The Elderly ACS II Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1457 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2017-12-19

Brief Summary

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The objective of this study is to compare reduced-dose prasugrel and standard dose clopidogrel in patients older than 74 years with ACS, including non-ST-elevation (NSTEACS) and ST-elevation (STEMI) patients, undergoing early PCI. The primary endpoint of the trial will be the one-year composite of (all-cause)death, myocardial infarction, stroke and re-hospitalization due to cardiovascular reasons or bleeding.

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Detailed Description

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Conditions

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Acute Coronary Syndrome Coronary Arteriosclerosis Myocardial Ischemia Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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prasugrel

prasugrel 60 mg loading dose, followed by 5 mg once daily until the end of follow-up

Group Type EXPERIMENTAL

prasugrel

Intervention Type DRUG

prasugrel 5 mg o.d.

clopidogrel

Clopidogrel 300 mg loading dose followed by 75 mg once day until the end of follow-up

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

75 mg o.d.

Interventions

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prasugrel

prasugrel 5 mg o.d.

Intervention Type DRUG

Clopidogrel

75 mg o.d.

Intervention Type DRUG

Other Intervention Names

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Efient Plavix

Eligibility Criteria

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Inclusion Criteria

\- Patients \>74 years of age hospitalized for an ACS, with or without STE, with an onset of symptoms during the previous 72 hours, and candidates to an early PCI.

Exclusion Criteria

* Eligible NSTEACS patients may be randomized after coronary angiography. To be eligible, NSTEACS patients must have at least one of the following characteristics:

* elevated troponin levels;
* diabetes mellitus;
* prior MI;
* at least one new ischemic episode while on standard treatment during the index hospitalization;
* ACS due to stent thrombosis.

* History of stroke or transient ischemic attack (TIA)
* Gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks prior to randomization.
* Hemoglobin level on admission \<10 g/dl, unless this is considered to be secondary to renal dysfunction or known myelodysplasia.
* Secondary causes of acute myocardial ischemia.
* Known current platelet count \< 90,000 cells/mL.
* Ongoing oral anticoagulant treatment or an INR known to be \>1.5 at the time of screening.
* Concomitant severe obstructive lung disease, malignancy or neurologic deficit limiting follow-up or adherence to the study protocol.
* Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days prior to randomization
* Inability to give at least verbal informed consent to the study.
* Contraindications to the use of clopidogrel or prasugrel as per package leaflet.

Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No